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A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

Primary Purpose

Cataract

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dexycu
Placebo/Vehicle
Sponsored by
EyePoint Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects at least 40 years of age scheduled for cataract surgery
  • Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye
  • Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye.

Exclusion Criteria:

  • Use of any corticosteroids within 7 days prior to Day 0
  • Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days
  • Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    DEXYCU

    Placebo

    Arm Description

    DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg

    Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg

    Outcomes

    Primary Outcome Measures

    Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8

    Secondary Outcome Measures

    Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30
    Mean ocular pain scores in the study eye
    Numerical Ocular Pain Scale from 0-10 with 0 being no pain and 10 being most severe
    Proportion of subjects with absence of cells in the AC of the study eye
    Proportion of subjects with absence of flare in the AC of the study eye
    Mean AC cell score in the study eye
    AC count by Slit Lamp Biomicroscopy with 0 being none and 4 being most severe
    Mean AC flare score in the study eye
    AC count by Slit Lamp Biomicroscopy with 0 being absent and 4 being strong intensity
    Rates of ocular (study eye and fellow eye) and non-ocular TEAEs

    Full Information

    First Posted
    September 16, 2022
    Last Updated
    September 21, 2022
    Sponsor
    EyePoint Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05550350
    Brief Title
    A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
    Official Title
    A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EyePoint Pharmaceuticals, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
    Detailed Description
    A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with Cataract Surgery

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DEXYCU
    Arm Type
    Experimental
    Arm Description
    DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg
    Intervention Type
    Drug
    Intervention Name(s)
    Dexycu
    Intervention Description
    103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg
    Intervention Type
    Other
    Intervention Name(s)
    Placebo/Vehicle
    Intervention Description
    Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg
    Primary Outcome Measure Information:
    Title
    Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8
    Time Frame
    Day 8
    Secondary Outcome Measure Information:
    Title
    Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30
    Time Frame
    Days 1, 3, 15, and 30
    Title
    Mean ocular pain scores in the study eye
    Description
    Numerical Ocular Pain Scale from 0-10 with 0 being no pain and 10 being most severe
    Time Frame
    Days 1, 3, 8, 15 and 30
    Title
    Proportion of subjects with absence of cells in the AC of the study eye
    Time Frame
    Days 1, 3, 8, 15 and 30
    Title
    Proportion of subjects with absence of flare in the AC of the study eye
    Time Frame
    Days 1, 3, 8, 15 and 30
    Title
    Mean AC cell score in the study eye
    Description
    AC count by Slit Lamp Biomicroscopy with 0 being none and 4 being most severe
    Time Frame
    Days 1, 3, 8, 15 and 30
    Title
    Mean AC flare score in the study eye
    Description
    AC count by Slit Lamp Biomicroscopy with 0 being absent and 4 being strong intensity
    Time Frame
    Days 1, 3, 8, 15 and 30
    Title
    Rates of ocular (study eye and fellow eye) and non-ocular TEAEs
    Time Frame
    up to day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female subjects at least 40 years of age scheduled for cataract surgery Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye. Exclusion Criteria: Use of any corticosteroids within 7 days prior to Day 0 Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dario Paggiarino, MD
    Phone
    8589670016
    Email
    dpaggiarino@eyepointpharma.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

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